Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CLVS | |
Entity Registrant Name | CLOVIS ONCOLOGY, INC. | |
Entity Central Index Key | 1,466,301 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 38,320,649 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenues: | ||||
License and milestone revenue | $ 13,625 | |||
Operating expenses: | ||||
Research and development | $ 76,138 | $ 34,965 | $ 193,256 | 87,556 |
General and administrative | 8,331 | 5,267 | 22,286 | 15,852 |
Acquired in-process research and development | 12,000 | 12,000 | 8,806 | |
Amortization of intangible asset | 3,409 | |||
Accretion of contingent purchase consideration | 783 | 888 | 2,271 | 2,571 |
Total expenses | 97,252 | 41,120 | 229,813 | 118,194 |
Operating loss | (97,252) | (41,120) | (229,813) | (104,569) |
Other income (expense): | ||||
Interest expense | (2,099) | (511) | (6,271) | (511) |
Foreign currency gains (losses) | (101) | 2,323 | 2,004 | 2,579 |
Other income (expense) | 179 | (42) | 252 | (134) |
Other income (expense), net | (2,021) | 1,770 | (4,015) | 1,934 |
Loss before income taxes | (99,273) | (39,350) | (233,828) | (102,635) |
Income tax benefit (expense) | 628 | (292) | 508 | (2,489) |
Net loss | $ (98,645) | $ (39,642) | $ (233,320) | $ (105,124) |
Basic and diluted net loss per common share | $ (2.62) | $ (1.17) | $ (6.62) | $ (3.10) |
Basic and diluted weighted average common shares outstanding | 37,613 | 33,921 | 35,252 | 33,871 |
Comprehensive loss | $ (98,222) | $ (58,809) | $ (250,358) | $ (126,126) |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 355,443 | $ 482,677 |
Available-for-sale securities | 250,444 | |
Prepaid research and development expenses | 2,394 | 3,765 |
Other current assets | 7,159 | 4,730 |
Total current assets | 615,440 | 491,172 |
Property and equipment, net | 3,303 | 2,718 |
Intangible assets | 196,390 | 212,900 |
Goodwill | 60,932 | 66,055 |
Other assets | 15,624 | 13,361 |
Total assets | 891,689 | 786,206 |
Current liabilities: | ||
Accounts payable | 9,316 | 2,917 |
Accrued research and development expenses | 58,954 | 37,257 |
Other accrued expenses | 7,667 | 7,598 |
Total current liabilities | 75,937 | 47,772 |
Contingent purchase consideration | 52,421 | 52,453 |
Deferred income taxes, net | 61,138 | 66,851 |
Convertible senior notes | 287,500 | 287,500 |
Deferred rent, long-term | 371 | |
Total liabilities | $ 477,367 | $ 454,576 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2015 and December 31, 2014 | ||
Common stock, $0.001 par value per share, 100,000,000 shares authorized at September 30, 2015 and December 31, 2014; 38,280,996 and 33,977,187 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively | $ 38 | $ 34 |
Additional paid-in capital | 1,118,135 | 785,089 |
Accumulated other comprehensive loss | (41,486) | (24,448) |
Accumulated deficit | (662,365) | (429,045) |
Total stockholders' equity | 414,322 | 331,630 |
Total liabilities and stockholders' equity | $ 891,689 | $ 786,206 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 38,280,996 | 33,977,187 |
Common stock, shares outstanding | 38,280,996 | 33,977,187 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Operating activities | ||
Net loss | $ (233,320) | $ (105,124) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 548 | 3,700 |
Share-based compensation expense | 29,458 | 15,585 |
Amortization of premiums and discounts on available-for-sale securities | 1,319 | |
Amortization of debt issuance costs | 900 | 72 |
Change in value of contingent purchase consideration | (32) | (309) |
Deferred income taxes | (529) | 761 |
Changes in operating assets and liabilities: | ||
Prepaid and accrued research and development expenses | 21,046 | 7,152 |
Other operating assets | (3,500) | (3,941) |
Accounts payable | 6,124 | (1,889) |
Other accrued expenses | 609 | 892 |
Net cash used in operating activities | (177,377) | (83,101) |
Investing activities | ||
Purchases of property and equipment | (1,175) | (2,191) |
Purchases of available-for-sale securities | (392,540) | |
Sales of available-for-sale securities | 140,996 | |
Net cash used in investing activities | (252,719) | (2,191) |
Financing activities | ||
Proceeds from the sale of common stock, net of issuance costs | 298,509 | |
Proceeds from the issuance of convertible senior notes, net of issuance costs | 278,335 | |
Proceeds from the exercise of stock options and employee stock purchases | 5,027 | 763 |
Net cash provided by financing activities | 303,536 | 279,098 |
Effect of exchange rate changes on cash and cash equivalents | (674) | (449) |
(Decrease) increase in cash and cash equivalents | (127,234) | 193,357 |
Cash and cash equivalents at beginning of period | 482,677 | 323,228 |
Cash and cash equivalents at end of period | 355,443 | $ 516,585 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | $ 7,307 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2015 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business and Basis of Presentation | 1. Nature of Business and Basis of Presentation Clovis Oncology, Inc. (the “Company”) is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the United States, Europe and other international markets. The Company has and intends to continue to license or acquire rights to oncology compounds in all stages of development. In exchange for the right to develop and commercialize these compounds, the Company generally expects to provide the licensor with a combination of up-front payments, milestone payments and royalties on future sales. In addition, the Company generally expects to assume the responsibility for future drug development and commercialization costs. The Company currently operates in one segment. Since inception, the Company’s operations have consisted primarily of developing in-licensed compounds, evaluating new product acquisition candidates and general corporate activities. In July 2015, the Company submitted a New Drug Application (“NDA”) regulatory filing and a Marketing Authorization Application (“MAA”) for rociletinib to the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”), respectively. Both the FDA and EMA subsequently accepted the respective filings for review. The FDA granted the rociletinib NDA priority review status with a Prescription Drug User Fee Act action date of March 30, 2016. Basis of Presentation All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries, Clovis Oncology UK Limited and Clovis Oncology Italy S.r.l. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments, consisting only of normal recurring adjustments, which in the opinion of management are necessary to fairly state our financial position, results of operations and cash flows for the periods presented. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a broader discussion of our business and the opportunities and risks inherent in such business. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, revenue and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to contingent purchase consideration, the allocation of purchase consideration, intangible asset impairment, clinical trial accruals and share-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Liquidity The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through debt and equity financings. Management expects operating losses and negative cash flows to continue for the foreseeable future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless or until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. See Note 10 for discussion of our recent common stock offering. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 2 of the Notes to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Recent Accounting Pronouncements In April 2015, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2015-03, “Interest – Imputation of Interest (Subtopic 835-30) – Simplifying the Presentation of Debt Issuance Costs.” ASU No. 2015-03 requires debt issuance costs to be presented as a deduction from the corresponding debt liability, rather than as an asset. This update is effective for fiscal years beginning after December 15, 2015, including interim periods within those years. Early adoption is permitted. Upon adoption, the guidance must be applied retrospectively to all periods presented in the financial statements. The Company has elected not to early adopt this standard. Adoption of the standard will impact the presentation of the Company’s debt issuance costs on the Consolidated Balance Sheets and the related disclosures. |
EOS Acquisition
EOS Acquisition | 9 Months Ended |
Sep. 30, 2015 | |
Business Combinations [Abstract] | |
EOS Acquisition | 3. EOS Acquisition On November 19, 2013, the Company acquired all of the outstanding common and preferred stock of Ethical Oncology Science, S.p.A. (“EOS”) (now known as Clovis Oncology Italy S.r.l.). The initial purchase consideration was comprised of an $11.8 million cash payment and the issuance of $173.7 million of the Company’s common stock to the former EOS shareholders. The Company may make additional purchase payments to the previous EOS shareholders if certain lucitanib regulatory and sales milestones are achieved. The potential contingent milestone payments range from a zero payment, which assumes lucitanib fails to achieve any of the regulatory milestones, to approximately $193.9 million ($65.0 million and €115.0 million) if all regulatory and sales milestones are met, utilizing the translation rate at September 30, 2015. The Company recorded a liability for the estimated fair value of these payments, which totaled $52.4 million and $52.5 million at September 30, 2015 and December 31, 2014, respectively. |
Financial Instruments and Fair
Financial Instruments and Fair Value Measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments and Fair Value Measurements | 4. Financial Instruments and Fair Value Measurements Cash, Cash Equivalents and Available-for-Sale Securities The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. Marketable securities with original maturities greater than three months are considered to be available-for-sale securities. Available-for-sale securities are reported at fair value and unrealized gains and losses are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense) on the Consolidated Statements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on management’s intent to fund current operations with these securities or to make them available for current operations. A decline in the market value of a security below its cost value that is deemed to be other than temporary is charged to earnings and results in the establishment of a new cost basis for the security. Fair Value Measurements Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs that may be used to measure fair value include: Level 1: Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of money market investments. The Company does not have Level 1 liabilities. Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s Level 2 assets include U.S. treasury securities. The Company does not have Level 2 liabilities. Level 3: Unobservable inputs that are supported by little or no market activity. The Company does not have Level 3 assets. The contingent purchase consideration related to the undeveloped lucitanib product rights acquired with the purchase of EOS is a Level 3 liability. The fair value of this liability is based on unobservable inputs and includes valuations for which there is little, if any, market activity. See Note 3 of the Company’s 2014 Form 10-K for further discussion of the unobservable inputs and valuation techniques related to the contingent purchase consideration liability. The following table identifies the Company’s assets and liabilities that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 September 30, 2015 Assets: Money market $ 325,843 $ 325,843 $ — $ — U.S. treasury securities 250,444 — 250,444 — Total assets at fair value $ 576,287 $ 325,843 $ 250,444 $ — Liabilities: Contingent purchase consideration $ 52,421 $ — $ — $ 52,421 Total liabilities at fair value $ 52,421 $ — $ — $ 52,421 December 31, 2014 Assets: Money market $ 447,994 $ 447,994 $ — $ — Total assets at fair value $ 447,994 $ 447,994 $ — $ — Liabilities: Contingent purchase consideration $ 52,453 $ — $ — $ 52,453 Total liabilities at fair value $ 52,453 $ — $ — $ 52,453 The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) (in thousands): For the Nine Months Ended September 30, 2015 Liabilities: Balance at beginning of period $ 52,453 Accretion 2,271 Change in foreign currency gains and losses (2,303 ) Balance at end of period $ 52,421 The change in the fair value of Level 3 instruments is included in accretion of contingent purchase consideration and foreign currency gains (losses) for changes in the foreign currency translation rate on the Consolidated Statements of Operations and Comprehensive Loss. Financial instruments not recorded at fair value include the Company’s convertible senior notes. At September 30, 2015, the carrying amount of the convertible senior notes was $287.5 million, which represents the aggregate principal amount, and the fair value was $480.1 million. The fair value was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the Notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system. See Note 9 for discussion of the convertible senior notes. |
Available-for-Sale Securities
Available-for-Sale Securities | 9 Months Ended |
Sep. 30, 2015 | |
Available For Sale Securities [Abstract] | |
Available-for-Sale Securities | 5. Available-for-Sale Securities As of September 30, 2015, available-for-sale securities consisted of the following (in thousands): Gross Gross Aggregate Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $ 250,296 $ 148 $ — $ 250,444 As of September 30, 2015, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands): Amortized Fair Cost Value Due in one year or less $ 175,171 $ 175,246 Due in one year to two years 75,125 75,198 Total $ 250,296 $ 250,444 |
Other Current Assets
Other Current Assets | 9 Months Ended |
Sep. 30, 2015 | |
Other Current Assets [Abstract] | |
Other Current Assets | 6. Other Current Assets Other current assets were comprised of the following (in thousands): September 30, December 31, 2015 2014 Receivable from partners $ 3,836 $ 1,991 Prepaid expenses- other 1,915 1,168 Prepaid insurance 491 1,190 Other 917 381 Total $ 7,159 $ 4,730 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 9 Months Ended |
Sep. 30, 2015 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Intangible Assets and Goodwill | 7. Intangible Assets and Goodwill Intangible acquired in-process research and development (“IPR&D”) assets and goodwill were established as part of the purchase accounting of EOS in November 2013. IPR&D assets and goodwill consisted of the following (in thousands): September 30, December 31, 2015 2014 IPR&D assets: Balance at beginning of period $ 212,900 $ 244,518 Change in foreign currency gains and losses (16,510 ) (28,209 ) Amortization of intangible asset — (3,409 ) (a) Balance at end of period $ 196,390 $ 212,900 Goodwill: Balance at beginning of period $ 66,055 $ 74,811 Change in foreign currency gains and losses (5,123 ) (8,756 ) Balance at end of period $ 60,932 $ 66,055 (a) During the first quarter of 2014, the Company recorded a $3.4 million reduction in the intangible assets driven by lower expected future milestone revenue from the lucitanib development activities due to the receipt of a lucitanib milestone payment from Servier (see Note 12). This reduction was reported as amortization of intangible asset on the Consolidated Statements of Operations and Comprehensive Loss. Recurring amortization of the IPR&D assets will commence when the useful lives of the intangible assets have been determined. IPR&D intangible assets are evaluated for impairment at least annually or more frequently if impairment indicators exist and any reduction in fair value will be recognized as an expense in the Consolidated Statements of Operations and Comprehensive Loss. |
Other Accrued Expenses
Other Accrued Expenses | 9 Months Ended |
Sep. 30, 2015 | |
Payables And Accruals [Abstract] | |
Other Accrued Expenses | 8. Other Accrued Expenses Other accrued expenses were comprised of the following (in thousands): September 30, December 31, 2015 2014 Accrued personnel costs $ 6,972 $ 4,726 Accrued interest payable 299 2,236 Income tax payable 125 411 Accrued expenses - other 271 225 Total $ 7,667 $ 7,598 |
Convertible Senior Notes
Convertible Senior Notes | 9 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
Convertible Senior Notes | 9. Convertible Senior Notes On September 9, 2014, we completed a private placement of $287.5 million aggregate principal amount of 2.5% convertible senior notes due 2021 (the “Notes”) resulting in net proceeds to the Company of $278.3 million after deducting offering expenses. In accordance with the accounting guidance, the conversion feature did not meet the criteria for bifurcation, and the entire principal amount was recorded as a long-term liability on the Consolidated Balance Sheets. The Notes are governed by the terms of the indenture between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee. The Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on March 15 and September 15 of each year, beginning March 15, 2015. The Notes will mature on September 15, 2021, unless earlier converted, redeemed or repurchased. Holders may convert all or any portion of the Notes at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the holders will receive shares of our common stock at an initial conversion rate of 16.1616 shares per $1,000 in principal amount of Notes, equivalent to a conversion price of approximately $61.88 per share. The conversion rate is subject to adjustment upon the occurrence of certain events described in the indenture, but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date or upon our issuance of a notice of redemption, we will increase the conversion rate for holders who elect to convert the Notes in connection with such a corporate event or during the related redemption period in certain circumstances. On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes. If we undergo a fundamental change, as defined in the indenture, prior to the maturity date of the Notes, holders may require us to repurchase for cash all or any portion of the Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Notes rank senior in right of payment to any of our indebtedness that is expressly subordinated in right of payment to the Notes; equal in right of payment to all of our liabilities that are not so subordinated; effectively junior in right of payment to any secured indebtedness to the extent of the value of the assets securing such indebtedness; and structurally junior to all indebtedness and other liabilities (including trade payables) of our subsidiaries. In connection with the issuance of the Notes, the Company incurred $9.2 million of debt issuance costs, which is included in other assets on the Consolidated Balance Sheets. The debt issuance costs are amortized as interest expense over the expected life of the Notes using the effective interest method. The Company determined the expected life of the debt was equal to the seven-year term of the Notes. As of September 30, 2015, the balance of unamortized debt issuance costs was $7.9 million. The following table sets forth total interest expense recognized related to the Notes during the three and nine months ended September 30, 2015 and 2014 (in thousands): Three Months Ended September 30, Nine Month Ended September 30, 2015 2014 2015 2014 Contractual interest expense $ 1,797 $ 439 $ 5,371 $ 439 Amortization of debt issuance costs 302 72 900 72 Total interest expense $ 2,099 $ 511 $ 6,271 $ 511 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Stockholders' Equity | 10. Stockholders’ Equity Common Stock In July 2015, the Company sold 4,054,487 shares of its common stock in a public offering at $78.00 per share. The net proceeds to the Company from the offering were $298.5 million, after deducting underwriting discounts and commissions and offering expenses. Accumulated Other Comprehensive Loss Accumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which includes changes in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities. The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): Total Foreign Accumulated Currency Other Translation Unrealized Comprehensive Adjustments Gains Income (Loss) Balance December 31, 2013 $ 4,696 $ — $ 4,696 Period change (29,144 ) — (29,144 ) Balance December 31, 2014 (24,448 ) — (24,448 ) Period change (17,186 ) 148 (17,038 ) Balance September 30, 2015 $ (41,634 ) $ 148 $ (41,486 ) The period change between September 30, 2015 and December 31, 2014 was primarily due to the currency translation of the IPR&D intangible assets, goodwill and deferred income taxes associated with the acquisition of EOS in November 2013 (see Notes 3 and 7). |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | 11. Share-Based Compensation Share-based compensation expense for all equity based programs, including stock options and the employee stock purchase plan, for the three and nine months ended September 30, 2015 and 2014 was recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development (a) $ 9,039 $ 2,991 $ 19,798 $ 8,005 General and administrative 3,367 2,445 9,660 7,580 Total share-based compensation expense $ 12,406 $ 5,436 $ 29,458 $ 15,585 (a) During the third quarter of 2015, the Company recognized $2.9 million in share-based compensation expense associated with a modification to the terms of a former executive’s stock option agreement. The Company did not recognize a tax benefit related to share-based compensation expense during the three and nine months ended September 30, 2015 and 2014, respectively, as the Company maintains net operating loss carryforwards and has established a valuation allowance against the entire net deferred tax asset as of September 30, 2015. The following table summarizes the activity relating to the Company’s options to purchase common stock: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2014 4,159,362 $ 37.69 Granted 1,476,093 (a) 81.89 Exercised (239,144 ) 18.96 Forfeited (99,141 ) 54.89 Outstanding at September 30, 2015 5,297,170 $ 50.53 7.9 $ 220,000 Vested and expected to vest at September 30, 2015 4,927,425 $ 49.06 7.8 $ 211,831 Exercisable at September 30, 2015 2,335,441 $ 31.51 6.5 $ 141,187 (a) Includes 120,000 performance-based stock options granted to executives of the Company in the first quarter of 2015. Fifty-percent of the grant vests contingent on approval by the FDA to commercially distribute, sell or market rociletinib and fifty-percent of the grant vests contingent on approval by the FDA to commercially distribute, sell or market rucaparib. Stock compensation expense will be recognized when the condition for vesting is probable of being met. The aggregate intrinsic value in the table above represents the pretax intrinsic value, based on our closing stock price of $91.96 as of September 30, 2015, which would have been received by the option holders had all option holders with in-the-money options exercised their options as of that date. The following table summarizes information about our stock options as of and for the three and nine months ended September 30, 2015 and 2014: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Weighted-average grant date fair value per share $ 56.22 $ 27.85 $ 52.98 $ 39.13 Intrinsic value of options exercised $ 5,307,365 $ 4,391 $ 15,361,206 $ 2,754,669 Cash received from stock option exercises $ 1,953,938 $ 341 $ 4,534,288 $ 541,508 As of September 30, 2015, the unrecognized share-based compensation expense related to nonvested options, adjusted for expected forfeitures, was $96.8 million and the estimated weighted-average remaining vesting period was 2.7 years. |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2015 | |
Research And Development [Abstract] | |
License Agreements | 12. License Agreements Rociletinib In May 2010, we entered into an exclusive worldwide license agreement with Avila Therapeutics, Inc. (now Celgene Avilomics Research, Inc., part of Celgene Corporation (“Celgene”)) to discover, develop and commercialize a covalent inhibitor of mutant forms of the epidermal growth factor receptor gene product. As a result of the collaboration contemplated by the agreement, rociletinib was identified as the lead inhibitor candidate, which we are developing under the terms of the license agreement. We are responsible for all preclinical, clinical, regulatory and other activities necessary to develop and commercialize rociletinib. We made an up-front payment of $2.0 million upon execution of the license agreement, a $4.0 million milestone payment in the first quarter of 2012 upon acceptance by the FDA of our Investigational New Drug application for rociletinib and a $5.0 million milestone payment in the first quarter of 2014 upon initiation of the Phase II study for rociletinib. In the third quarter of 2015, we made milestone payments totaling $12.0 million upon acceptance of the NDA and MAA for rociletinib by the FDA and EMA, respectively. We recognized all payments prior to commercial approval as acquired in-process research and development expense. We are obligated to pay royalties on net sales of rociletinib, based on the volume of annual net sales achieved. The Company is required to pay up to an additional aggregate of $98.0 million in development and regulatory milestone payments if certain clinical study objectives and regulatory filings, acceptances and approvals are achieved, including $15.0 million upon the first approval of an NDA by the FDA and $15.0 million upon the first approval of an MAA by the EMA. In addition, the Company is required to pay up to an aggregate of $120.0 million in sales milestone payments if certain annual sales targets are achieved. Rucaparib In June 2011, the Company entered into a worldwide license agreement with Pfizer Inc. to acquire exclusive development and commercialization rights to rucaparib. This drug candidate is a small molecule inhibitor of poly ADP-ribose polymerase, which the Company is developing for the treatment of selected solid tumors. Pursuant to the terms of the license agreement, the Company made a $7.0 million up-front payment to Pfizer. In April 2014, the Company initiated a pivotal registration study for rucaparib, which resulted in a $0.4 million milestone payment to Pfizer as required by the license agreement. This payment was recognized as acquired in-process research and development expense. The Company is responsible for all development and commercialization costs of rucaparib. When and if commercial sales of rucaparib begin, we will pay Pfizer tiered royalties on our net sales. In addition, Pfizer is eligible to receive up to $258.5 million of further payments, in aggregate, if certain development, regulatory and sales milestones are achieved. Lucitanib In connection with its November 2013 acquisition of EOS, the Company gained rights to develop and commercialize lucitanib, an oral, selective tyrosine kinase inhibitor. As further described below, EOS licensed the worldwide rights, excluding China, to develop and commercialize lucitanib from Advenchen Laboratories LLC (“Advenchen”). Subsequently, rights to develop and commercialize lucitanib in markets outside the U.S. and Japan were sublicensed by EOS to Les Laboratoires Servier (“Servier”) in exchange for up-front milestone fees, royalties on sales of lucitanib in the sublicensed territories and research and development funding commitments. In October 2008, EOS entered into an exclusive license agreement with Advenchen to develop and commercialize lucitanib on a global basis, excluding China. The Company is obligated to pay Advenchen royalties on net sales of lucitanib, based on the volume of annual net sales achieved. In addition, the Company is obligated to pay to Advenchen 25% of any consideration, excluding royalties, received pursuant to any sublicense agreements for lucitanib, including the agreement with Servier. In the first quarter of 2014, the Company recognized acquired in-process research and development expense of $3.4 million, which represents 25% of the sublicense agreement consideration of $13.6 million received from Servier upon the end of opposition and appeal of the lucitanib patent by the European Patent Office. In September 2012, EOS entered into a collaboration and license agreement with Servier whereby EOS sublicensed to Servier exclusive rights to develop and commercialize lucitanib in all countries outside of the U.S., Japan and China. In exchange for these rights, EOS received an up-front payment and is entitled to receive additional payments upon achievement of specified development, regulatory and commercial milestones up to an additional €90.0 million in the aggregate. In addition, the Company is entitled to receive sales milestone payments if specified annual sales targets for lucitanib are met, which, in the aggregate, could total €250.0 million. The Company is also entitled to receive royalties on net sales of lucitanib by Servier. The development, regulatory and commercial milestones represent non-refundable amounts that would be paid by Servier to the Company if certain milestones are achieved in the future. These milestones, if achieved, are substantive as they relate solely to past performance, are commensurate with estimated enhancement of value associated with the achievement of each milestone as a result of the Company's performance, which are reasonable relative to the other deliverables and terms of the arrangement, and are unrelated to the delivery of any further elements under the arrangement. The Company and Servier are developing lucitanib pursuant to a development plan agreed to between the parties. Servier is responsible for all of the initial global development costs under the agreed upon plan up to €80.0 million. Cumulative global development costs, if any, in excess of €80.0 million will be shared equally between the Company and Servier. Beginning in the third quarter of 2014, depending on the expense type, reimbursements are determined using a standard rate approved by the Company and Servier or actual costs incurred. Previously, reimbursements were determined based on actual costs. Reimbursements are recorded as a reduction to research and development expense in the Consolidated Statements of Operations and Comprehensive Loss. The Company recorded a $3.8 million and $2.0 million receivable at September 30, 2015 and December 31, 2014, respectively, for the reimbursable development costs incurred under the global development plan, which is included in other current assets on the Consolidated Balance Sheets. For the three months ending September 30, 2015 and 2014, we incurred $3.8 million and $2.2 million, respectively, in research and development costs and recorded reductions in research and development expense of $3.8 million and $4.1 million, respectively, for reimbursable development costs due from Servier. For the nine months ending September 30, 2015 and 2014, we incurred $11.7 million and $9.8 million, respectively, in research and development costs and recorded reductions in research and development expense of $10.4 million and $7.9 million, respectively, for reimbursable development costs due from Servier. |
Net Loss Per Common Share
Net Loss Per Common Share | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 13. Net Loss Per Common Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury-stock method for the stock options and the if-converted method for the Notes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share. The shares outstanding at the end of the respective periods presented in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in thousands): Three and Nine Months Ended September 30, 2015 2014 Common shares under option 5,232 2,662 Convertible senior notes 4,646 4,646 Total potential dilutive shares 9,878 7,308 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies The Company has entered into certain license agreements, as identified in Note 12, with third parties that include the payment of development and regulatory milestones, as well as royalty payments, upon the achievement of pre-established development, regulatory and commercial targets. The Company’s payment obligation related to these license agreements is contingent upon the successful development, regulatory approval and commercialization of the licensed products. Due to the nature of these arrangements, the future potential payments are inherently uncertain, and accordingly, no amounts have been recorded in the Company’s Consolidated Balance Sheets at September 30, 2015 and December 31, 2014. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events The Company evaluated events up to the filing date of these interim financial statements and determined that no subsequent activity required disclosure. |
Nature of Business and Basis 21
Nature of Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation All financial information presented includes the accounts of the Company and its wholly-owned subsidiaries, Clovis Oncology UK Limited and Clovis Oncology Italy S.r.l. All significant intercompany balances and transactions have been eliminated in consolidation. The unaudited financial statements of Clovis Oncology, Inc. included herein reflect all adjustments, consisting only of normal recurring adjustments, which in the opinion of management are necessary to fairly state our financial position, results of operations and cash flows for the periods presented. Interim results may not be indicative of the results that may be expected for the full year. Certain information and footnote disclosures normally included in audited financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto which are included in our Annual Report on Form 10-K for the year ended December 31, 2014 for a broader discussion of our business and the opportunities and risks inherent in such business. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, revenue and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to contingent purchase consideration, the allocation of purchase consideration, intangible asset impairment, clinical trial accruals and share-based compensation expense. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. |
Liquidity | Liquidity The Company has incurred significant net losses since inception and has relied on its ability to fund its operations through debt and equity financings. Management expects operating losses and negative cash flows to continue for the foreseeable future. As the Company continues to incur losses, transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support the Company’s cost structure. The Company may never achieve profitability, and unless or until it does, the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings and may seek additional capital through arrangements with strategic partners or from other sources. See Note 10 for discussion of our recent common stock offering. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In April 2015, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2015-03, “Interest – Imputation of Interest (Subtopic 835-30) – Simplifying the Presentation of Debt Issuance Costs.” ASU No. 2015-03 requires debt issuance costs to be presented as a deduction from the corresponding debt liability, rather than as an asset. This update is effective for fiscal years beginning after December 15, 2015, including interim periods within those years. Early adoption is permitted. Upon adoption, the guidance must be applied retrospectively to all periods presented in the financial statements. The Company has elected not to early adopt this standard. Adoption of the standard will impact the presentation of the Company’s debt issuance costs on the Consolidated Balance Sheets and the related disclosures. |
Cash, Cash Equivalents and Available-for-Sale Securities | Cash, Cash Equivalents and Available-for-Sale Securities The Company considers all highly liquid investments with original maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in certificate of deposits, commercial paper and U.S. government and U.S. government agency obligations. Marketable securities with original maturities greater than three months are considered to be available-for-sale securities. Available-for-sale securities are reported at fair value and unrealized gains and losses are included in accumulated other comprehensive loss on the Consolidated Balance Sheets. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other income (expense) on the Consolidated Statements of Operations and Comprehensive Loss. The cost of investments for purposes of computing realized and unrealized gains and losses is based on the specific identification method. Investments with maturities beyond one year are classified as short-term based on management’s intent to fund current operations with these securities or to make them available for current operations. A decline in the market value of a security below its cost value that is deemed to be other than temporary is charged to earnings and results in the establishment of a new cost basis for the security. |
Fair Value Measurements | Fair Value Measurements Fair value is defined as the exchange price that would be received to sell an asset or paid to transfer a liability (at exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The three levels of inputs that may be used to measure fair value include: Level 1: Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of money market investments. The Company does not have Level 1 liabilities. Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s Level 2 assets include U.S. treasury securities. The Company does not have Level 2 liabilities. Level 3: Unobservable inputs that are supported by little or no market activity. The Company does not have Level 3 assets. The contingent purchase consideration related to the undeveloped lucitanib product rights acquired with the purchase of EOS is a Level 3 liability. The fair value of this liability is based on unobservable inputs and includes valuations for which there is little, if any, market activity. See Note 3 of the Company’s 2014 Form 10-K for further discussion of the unobservable inputs and valuation techniques related to the contingent purchase consideration liability. |
Intangible Assets and Goodwill | Recurring amortization of the IPR&D assets will commence when the useful lives of the intangible assets have been determined. IPR&D intangible assets are evaluated for impairment at least annually or more frequently if impairment indicators exist and any reduction in fair value will be recognized as an expense in the Consolidated Statements of Operations and Comprehensive Loss. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss Accumulated other comprehensive loss consists of changes in foreign currency translation adjustments, which includes changes in a subsidiary’s functional currency, and unrealized gains and losses on available-for-sale securities. |
Lucitanib | Reimbursements are recorded as a reduction to research and development expense in the Consolidated Statements of Operations and Comprehensive Loss. |
Net Loss Per Common Share | Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common share equivalents outstanding using the treasury-stock method for the stock options and the if-converted method for the Notes. As a result of our net losses for the periods presented, all potentially dilutive common share equivalents were considered anti-dilutive and were excluded from the computation of diluted net loss per share. |
Financial Instruments and Fai22
Financial Instruments and Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table identifies the Company’s assets and liabilities that were measured at fair value on a recurring basis (in thousands): Balance Level 1 Level 2 Level 3 September 30, 2015 Assets: Money market $ 325,843 $ 325,843 $ — $ — U.S. treasury securities 250,444 — 250,444 — Total assets at fair value $ 576,287 $ 325,843 $ 250,444 $ — Liabilities: Contingent purchase consideration $ 52,421 $ — $ — $ 52,421 Total liabilities at fair value $ 52,421 $ — $ — $ 52,421 December 31, 2014 Assets: Money market $ 447,994 $ 447,994 $ — $ — Total assets at fair value $ 447,994 $ 447,994 $ — $ — Liabilities: Contingent purchase consideration $ 52,453 $ — $ — $ 52,453 Total liabilities at fair value $ 52,453 $ — $ — $ 52,453 |
Roll-forward of Fair Value of Level 3 Instruments (significant unobservable inputs) | The following table rolls forward the fair value of Level 3 instruments (significant unobservable inputs) (in thousands): For the Nine Months Ended September 30, 2015 Liabilities: Balance at beginning of period $ 52,453 Accretion 2,271 Change in foreign currency gains and losses (2,303 ) Balance at end of period $ 52,421 |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Available For Sale Securities [Abstract] | |
Summary of Available-for-Sale Securities | As of September 30, 2015, available-for-sale securities consisted of the following (in thousands): Gross Gross Aggregate Amortized Unrealized Unrealized Fair Cost Gains Losses Value U.S. treasury securities $ 250,296 $ 148 $ — $ 250,444 |
Summary of Amortized Cost and Fair Value of Available-for-Sale Securities by Contractual Maturity | As of September 30, 2015, the amortized cost and fair value of available-for-sale securities by contractual maturity were (in thousands): Amortized Fair Cost Value Due in one year or less $ 175,171 $ 175,246 Due in one year to two years 75,125 75,198 Total $ 250,296 $ 250,444 |
Other Current Assets (Tables)
Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Other Current Assets [Abstract] | |
Other Current Assets | Other current assets were comprised of the following (in thousands): September 30, December 31, 2015 2014 Receivable from partners $ 3,836 $ 1,991 Prepaid expenses- other 1,915 1,168 Prepaid insurance 491 1,190 Other 917 381 Total $ 7,159 $ 4,730 |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of IPR&D Assets and Goodwill | IPR&D assets and goodwill consisted of the following (in thousands): September 30, December 31, 2015 2014 IPR&D assets: Balance at beginning of period $ 212,900 $ 244,518 Change in foreign currency gains and losses (16,510 ) (28,209 ) Amortization of intangible asset — (3,409 ) (a) Balance at end of period $ 196,390 $ 212,900 Goodwill: Balance at beginning of period $ 66,055 $ 74,811 Change in foreign currency gains and losses (5,123 ) (8,756 ) Balance at end of period $ 60,932 $ 66,055 (a) During the first quarter of 2014, the Company recorded a $3.4 million reduction in the intangible assets driven by lower expected future milestone revenue from the lucitanib development activities due to the receipt of a lucitanib milestone payment from Servier (see Note 12). This reduction was reported as amortization of intangible asset on the Consolidated Statements of Operations and Comprehensive Loss. |
Other Accrued Expenses (Tables)
Other Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Payables And Accruals [Abstract] | |
Other Accrued Expenses | Other accrued expenses were comprised of the following (in thousands): September 30, December 31, 2015 2014 Accrued personnel costs $ 6,972 $ 4,726 Accrued interest payable 299 2,236 Income tax payable 125 411 Accrued expenses - other 271 225 Total $ 7,667 $ 7,598 |
Convertible Senior Notes (Table
Convertible Senior Notes (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Debt Disclosure [Abstract] | |
Schedule of Total Interest Expense Recognized Related to Notes | The following table sets forth total interest expense recognized related to the Notes during the three and nine months ended September 30, 2015 and 2014 (in thousands): Three Months Ended September 30, Nine Month Ended September 30, 2015 2014 2015 2014 Contractual interest expense $ 1,797 $ 439 $ 5,371 $ 439 Amortization of debt issuance costs 302 72 900 72 Total interest expense $ 2,099 $ 511 $ 6,271 $ 511 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Component of Other Comprehensive Income (Loss) | The accumulated balances related to each component of other comprehensive income (loss) are summarized as follows (in thousands): Total Foreign Accumulated Currency Other Translation Unrealized Comprehensive Adjustments Gains Income (Loss) Balance December 31, 2013 $ 4,696 $ — $ 4,696 Period change (29,144 ) — (29,144 ) Balance December 31, 2014 (24,448 ) — (24,448 ) Period change (17,186 ) 148 (17,038 ) Balance September 30, 2015 $ (41,634 ) $ 148 $ (41,486 ) |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations | Share-based compensation expense for all equity based programs, including stock options and the employee stock purchase plan, for the three and nine months ended September 30, 2015 and 2014 was recognized in the accompanying Consolidated Statements of Operations and Comprehensive Loss as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development (a) $ 9,039 $ 2,991 $ 19,798 $ 8,005 General and administrative 3,367 2,445 9,660 7,580 Total share-based compensation expense $ 12,406 $ 5,436 $ 29,458 $ 15,585 (a) During the third quarter of 2015, the Company recognized $2.9 million in share-based compensation expense associated with a modification to the terms of a former executive’s stock option agreement. |
Summary of Stock Options Activity | The following table summarizes the activity relating to the Company’s options to purchase common stock: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2014 4,159,362 $ 37.69 Granted 1,476,093 (a) 81.89 Exercised (239,144 ) 18.96 Forfeited (99,141 ) 54.89 Outstanding at September 30, 2015 5,297,170 $ 50.53 7.9 $ 220,000 Vested and expected to vest at September 30, 2015 4,927,425 $ 49.06 7.8 $ 211,831 Exercisable at September 30, 2015 2,335,441 $ 31.51 6.5 $ 141,187 (a) Includes 120,000 performance-based stock options granted to executives of the Company in the first quarter of 2015. Fifty-percent of the grant vests contingent on approval by the FDA to commercially distribute, sell or market rociletinib and fifty-percent of the grant vests contingent on approval by the FDA to commercially distribute, sell or market rucaparib. Stock compensation expense will be recognized when the condition for vesting is probable of being met. |
Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award | The following table summarizes information about our stock options as of and for the three and nine months ended September 30, 2015 and 2014: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Weighted-average grant date fair value per share $ 56.22 $ 27.85 $ 52.98 $ 39.13 Intrinsic value of options exercised $ 5,307,365 $ 4,391 $ 15,361,206 $ 2,754,669 Cash received from stock option exercises $ 1,953,938 $ 341 $ 4,534,288 $ 541,508 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Shares Outstanding Excluded from Calculation of Diluted Net Loss Per Share | The shares outstanding at the end of the respective periods presented in the table below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in thousands): Three and Nine Months Ended September 30, 2015 2014 Common shares under option 5,232 2,662 Convertible senior notes 4,646 4,646 Total potential dilutive shares 9,878 7,308 |
Nature of Business and Basis 31
Nature of Business and Basis of Presentation - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2015Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segments | 1 |
EOS Acquisition - Additional In
EOS Acquisition - Additional Information (Detail) - Ethical Oncology Science, S.p.A. | Nov. 19, 2013USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2014USD ($) | Nov. 19, 2013EUR (€) |
Business Acquisition [Line Items] | ||||
Business acquisition cash payments made on acquisition | $ 11,800,000 | |||
Future maximum contingent milestone payments | 193,900,000 | |||
Fair value of contingent consideration | $ 52,400,000 | $ 52,500,000 | ||
Regulatory and Sales Milestones | ||||
Business Acquisition [Line Items] | ||||
Future maximum contingent milestone payments | 65,000,000 | € 115,000,000 | ||
Future minimum contingent milestone payments | 0 | € 0 | ||
Common Stock | ||||
Business Acquisition [Line Items] | ||||
Business acquisition, common stock issued at acquisition date | $ 173,700,000 |
Assets and Liabilities Measured
Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | $ 576,287 | $ 447,994 |
Contingent purchase consideration, fair value | 52,421 | 52,453 |
Liabilities at fair value | 52,421 | 52,453 |
Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | 325,843 | 447,994 |
Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | 250,444 | |
Fair Value, Inputs, Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Contingent purchase consideration, fair value | 52,421 | 52,453 |
Liabilities at fair value | 52,421 | 52,453 |
Money Market | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | 325,843 | 447,994 |
Money Market | Fair Value, Inputs, Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | 325,843 | $ 447,994 |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | 250,444 | |
U.S. Treasury Securities | Fair Value, Inputs, Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets at fair value | $ 250,444 |
Roll-forward of Fair Value of L
Roll-forward of Fair Value of Level 3 Instruments (significant unobservable inputs) (Detail) - Fair Value, Inputs, Level 3 $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Balance at beginning of period | $ 52,453 |
Accretion | 2,271 |
Change in foreign currency gains and losses | (2,303) |
Balance at end of period | $ 52,421 |
Financial Instruments and Fai35
Financial Instruments and Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 | Sep. 09, 2014 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Convertible senior notes | $ 287,500 | $ 287,500 | |
Convertible Senior Unsecured Notes | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Convertible senior notes | 287,500 | $ 287,500 | |
Convertible Senior Unsecured Notes | Fair Value, Inputs, Level 2 | |||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |||
Convertible senior notes, fair value | $ 480,100 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-Sale Securities (Details) $ in Thousands | Sep. 30, 2015USD ($) |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | $ 250,296 |
Aggregate Fair Value | 250,444 |
U.S. Treasury Securities | |
Schedule Of Available For Sale Securities [Line Items] | |
Amortized Cost | 250,296 |
Gross Unrealized Gains | 148 |
Aggregate Fair Value | $ 250,444 |
Available-for-Sale Securities37
Available-for-Sale Securities - Summary of Amortized Cost and Fair Value of Available-for-Sale Securities by Contractual Maturity (Details) $ in Thousands | Sep. 30, 2015USD ($) |
Available For Sale Securities Debt Maturities [Abstract] | |
Amortized Cost, Due in one year or less | $ 175,171 |
Amortized Cost, Due in one year to two years | 75,125 |
Amortized Cost | 250,296 |
Fair Value, Due in one year or less | 175,246 |
Fair Value, Due in one year to two years | 75,198 |
Aggregate Fair Value | $ 250,444 |
Other Current Assets (Detail)
Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Other Current Assets [Abstract] | ||
Receivable from partners | $ 3,836 | $ 1,991 |
Prepaid expenses- other | 1,915 | 1,168 |
Prepaid insurance | 491 | 1,190 |
Other | 917 | 381 |
Other current assets | $ 7,159 | $ 4,730 |
Summary of IPR&D Assets and Goo
Summary of IPR&D Assets and Goodwill (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Mar. 31, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
IPR&D assets: | ||||
Balance at beginning of period | $ 212,900 | |||
Amortization of intangible asset | $ (3,400) | $ (3,409) | ||
Balance at end of period | 196,390 | $ 212,900 | ||
Goodwill: | ||||
Balance at beginning of period | 66,055 | |||
Balance at end of period | 60,932 | 66,055 | ||
In Process Research and Development | ||||
IPR&D assets: | ||||
Balance at beginning of period | 244,518 | 212,900 | 244,518 | 244,518 |
Change in foreign currency gains and losses | (16,510) | (28,209) | ||
Amortization of intangible asset | (3,409) | |||
Balance at end of period | 196,390 | 212,900 | ||
Ethical Oncology Science, S.p.A. | ||||
Goodwill: | ||||
Balance at beginning of period | $ 74,811 | 66,055 | $ 74,811 | 74,811 |
Change in foreign currency gains and losses | (5,123) | (8,756) | ||
Balance at end of period | $ 60,932 | $ 66,055 |
Summary of IPR&D Assets and G40
Summary of IPR&D Assets and Goodwill (Parenthetical) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Mar. 31, 2014 | Sep. 30, 2014 | |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Amortization of intangible asset | $ 3,400 | $ 3,409 |
Other Accrued Expenses (Detail)
Other Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Payables And Accruals [Abstract] | ||
Accrued personnel costs | $ 6,972 | $ 4,726 |
Accrued interest payable | 299 | 2,236 |
Income tax payable | 125 | 411 |
Accrued expenses - other | 271 | 225 |
Other accrued expenses | $ 7,667 | $ 7,598 |
Convertible Senior Notes - Addi
Convertible Senior Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | Sep. 09, 2014USD ($)TD$ / shares | Sep. 30, 2015USD ($)TD | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($) |
Debt Instrument [Line Items] | ||||
Convertible senior notes, aggregate principal amount | $ 287,500 | $ 287,500 | ||
Net proceeds from convertible senior notes | $ 278,335 | |||
Convertible Senior Unsecured Notes | ||||
Debt Instrument [Line Items] | ||||
Convertible senior notes, aggregate principal amount | $ 287,500 | $ 287,500 | ||
Convertible senior notes, interest rate | 2.50% | |||
Net proceeds from convertible senior notes | $ 278,335 | |||
Convertible senior notes, frequency of periodic payment | semi-annually | |||
Convertible senior notes, beginning date of periodic payment | Mar. 15, 2015 | |||
Convertible senior notes, maturity date | Sep. 15, 2021 | |||
Convertible senior notes, initial conversion price per share | $ / shares | $ 61.88 | |||
Common stock initial conversion rate per $1,000 in principal amount | 16.1616 | |||
Last reported sale price of common stock | 150.00% | |||
Debt instrument, conversion in effect for number of trading days | TD | 20 | |||
Debt instrument conversion, consecutive trading day period | 30 days | |||
Debt instrument redemption price percentage to principal amount | 100.00% | |||
Debt instrument redemption description | On or after September 15, 2018, we may redeem the Notes, at our option, in whole or in part, if the last reported sale price of our common stock has been at least 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending not more than two trading days preceding the date on which we provide written notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes. | |||
Debt instrument, redemption period start date | Sep. 15, 2018 | |||
Debt instrument, trading days preceding redemption notice, maximum | TD | 2 | |||
Debt instrument repurchase percentage | 100.00% | |||
Debt issuance costs | $ 9,200 | |||
Debt instrument term | 7 years | |||
Unamortized debt issuance costs | $ 7,900 | |||
Convertible Senior Unsecured Notes | Semi Annual Payment, First payment date | ||||
Debt Instrument [Line Items] | ||||
Interest payment date on senior notes | --03-15 | |||
Convertible Senior Unsecured Notes | Semi Annual Payment, Second payment date | ||||
Debt Instrument [Line Items] | ||||
Interest payment date on senior notes | --09-15 |
Schedule of Total Interest Expe
Schedule of Total Interest Expense Recognized Related to Notes (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Debt Disclosure [Abstract] | ||||
Contractual interest expense | $ 1,797 | $ 439 | $ 5,371 | $ 439 |
Amortization of debt issuance costs | 302 | 72 | 900 | 72 |
Total interest expense | $ 2,099 | $ 511 | $ 6,271 | $ 511 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended |
Jul. 31, 2015 | Sep. 30, 2015 | |
Equity [Abstract] | ||
Common stock, shares issued | 4,054,487 | |
Sale of stock, price per share | $ 78 | |
Proceeds from the sale of common stock, net of issuance costs | $ 298,500 | $ 298,509 |
Component of Other Comprehensiv
Component of Other Comprehensive Income (Loss) (Detail) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Beginning balance | $ (24,448) | $ 4,696 |
Period change | (17,038) | (29,144) |
Ending balance | (41,486) | (24,448) |
Foreign Currency Translation Adjustments | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Beginning balance | (24,448) | 4,696 |
Period change | (17,186) | (29,144) |
Ending balance | (41,634) | $ (24,448) |
Unrealized Gains | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Period change | 148 | |
Ending balance | $ 148 |
Share-Based Compensation Expens
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 12,406 | $ 5,436 | $ 29,458 | $ 15,585 |
Research and development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | 9,039 | 2,991 | 19,798 | 8,005 |
General and administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 3,367 | $ 2,445 | $ 9,660 | $ 7,580 |
Share-Based Compensation Expe47
Share-Based Compensation Expense Recognized in Accompanying Statements of Operations (Parenthetical) (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 12,406 | $ 5,436 | $ 29,458 | $ 15,585 |
Stock Option [Member] | Executive Officer [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 2,900 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||
Share-based compensation expense, tax benefit recognized | $ 0 | $ 0 | $ 0 | $ 0 |
Pretax intrinsic value, closing stock price | $ 91.96 | $ 91.96 | ||
Unrecognized stock-based compensation expense related to nonvested options | $ 96,800,000 | $ 96,800,000 | ||
Unrecognized stock-based compensation expense related to nonvested options, weighted-average remaining vesting period | 2 years 8 months 12 days |
Summary of Stock Options Activi
Summary of Stock Options Activity (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Beginning Balance, Number of Options Outstanding | shares | 4,159,362 |
Number of Options, Granted | shares | 1,476,093 |
Number of Options, Exercised | shares | (239,144) |
Number of Options, Forfeited | shares | (99,141) |
Ending Balance, Number of Options Outstanding | shares | 5,297,170 |
Number of Options, Vested and expected to vest at September 30, 2015 | shares | 4,927,425 |
Number of Options, Exercisable at September 30, 2015 | shares | 2,335,441 |
Beginning Balance, Weighted Average Exercise Price | $ 37.69 |
Granted, Weighted Average Exercise Price | 81.89 |
Exercised, Weighted Average Exercise Price | 18.96 |
Forfeited, Weighted Average Exercise Price | 54.89 |
Ending Balance, Weighted Average Exercise Price | 50.53 |
Vested and expected to vest, Weighted Average Exercise Price | 49.06 |
Exercisable, Weighted Average Exercise Price | $ 31.51 |
Outstanding, Weighted Average Remaining Contractual Term (Years) | 7 years 10 months 24 days |
Vested and expected to vest, Weighted Average Remaining Contractual Term (Years) | 7 years 9 months 18 days |
Exercisable, Weighted Average Remaining Contractual Term (Years) | 6 years 6 months |
Outstanding, Aggregate Intrinsic Value | $ | $ 220,000 |
Vested and expected to vest, Aggregate Intrinsic Value | $ | 211,831 |
Exercisable, Aggregate Intrinsic Value | $ | $ 141,187 |
Summary of Stock Options Acti50
Summary of Stock Options Activity (Parenthetical) (Detail) - shares | 3 Months Ended | 9 Months Ended |
Mar. 31, 2015 | Sep. 30, 2015 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Granted | 1,476,093 | |
Performance Shares | Contingent on FDA Approval to Commercially Distribute, Sell or Market Rociletinib | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Percentage of grant vest contingent on approval | 50.00% | |
Performance Shares | Contingent on FDA Approval to Commercially Distribute, Sell or Market Rucaparib | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Percentage of grant vest contingent on approval | 50.00% | |
Performance Shares | Executive Officer [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Granted | 120,000 |
Schedule of Share-Based Compens
Schedule of Share-Based Compensation Arrangements by Share-Based Payment Award (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||
Weighted-average grant date fair value per share | $ 56.22 | $ 27.85 | $ 52.98 | $ 39.13 |
Intrinsic value of options exercised | $ 5,307,365 | $ 4,391 | $ 15,361,206 | $ 2,754,669 |
Cash received from stock option exercises | $ 1,953,938 | $ 341 | $ 4,534,288 | $ 541,508 |
License Agreements - Additional
License Agreements - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Apr. 30, 2014USD ($) | Sep. 30, 2012EUR (€) | Jun. 30, 2011USD ($) | May. 31, 2010USD ($) | Oct. 31, 2008 | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Mar. 31, 2012USD ($) | Sep. 30, 2015USD ($) | Sep. 30, 2014USD ($) | Dec. 31, 2014USD ($) | |
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Acquired in process research and development costs | $ 12,000 | $ 12,000 | $ 8,806 | |||||||||
Development cost receivable | 3,836 | 3,836 | $ 1,991 | |||||||||
Research and development | 76,138 | $ 34,965 | 193,256 | 87,556 | ||||||||
License Agreements Lucitanib | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Sublicense agreement consideration | $ 13,600 | |||||||||||
Additional payments receivable on milestone achievements | € | € 90,000,000 | |||||||||||
Additional payments receivable on attaining the sales target | € | 250,000,000 | |||||||||||
Initial global development costs reimbursable | € | € 80,000,000 | |||||||||||
Development cost receivable | 3,800 | 3,800 | $ 2,000 | |||||||||
Research and development | 3,800 | 2,200 | 11,700 | 9,800 | ||||||||
Reduction in research and development expense for reimbursable development costs due from Servier | 3,800 | $ 4,100 | 10,400 | $ 7,900 | ||||||||
License Agreement Terms | License Agreements Licensor Celgene Avilomics Research Inc | Name of drug product in-licensed by the entity - Rociletinib | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Up-front payment | $ 2,000 | |||||||||||
Future expected regulatory and development payment | 98,000 | |||||||||||
Sales milestone payments | 120,000 | |||||||||||
License Agreement Terms | License Agreements Licensor Celgene Avilomics Research Inc | Name of drug product in-licensed by the entity - Rociletinib | FDA [Member] | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Future expected regulatory and development payment | 15,000 | |||||||||||
License Agreement Terms | License Agreements Licensor Celgene Avilomics Research Inc | Name of drug product in-licensed by the entity - Rociletinib | EMA [Member] | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Future expected regulatory and development payment | 15,000 | |||||||||||
License Agreement Terms | License Agreements Licensor Pfizer | Rucaparib | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Up-front payment | $ 7,000 | |||||||||||
Acquired in process research and development costs | $ 400 | |||||||||||
Future expected development, regulatory and sales milestone payments | $ 258,500 | |||||||||||
License Agreement Terms | Advenchen Laboratories LLC | License Agreements Lucitanib | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Acquired in process research and development costs | 3,400 | |||||||||||
Percentage of Non-Royalty Consideration Payable on Sublicense Agreements | 25.00% | |||||||||||
Regulatory Milestone Payment | License Agreement Terms | License Agreements Licensor Celgene Avilomics Research Inc | Name of drug product in-licensed by the entity - Rociletinib | ||||||||||||
Research And Development Arrangement Contract To Perform For Others [Line Items] | ||||||||||||
Acquired in process research and development costs | $ 12,000 | $ 5,000 | $ 4,000 |
Shares Outstanding Excluded fro
Shares Outstanding Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 9,878 | 7,308 |
Common shares under option | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 5,232 | 2,662 |
Convertible senior notes | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Total potential dilutive shares | 4,646 | 4,646 |